`Starting Draft Discussion Paper on Histamine`.

JOINT FAO/WHO FOOD STANDARDS PROGRAMME
CODEX COMMITTEE ON FISH AND FISHERY PRODUCTS
Thirty-fourth Session
Norway
2015
EWG Starting Draft Discussion Paper on Histamine
Electronic Working Group led by Japan and the United States
At the 33rd Session CCFFP agreed to establish an electronic working group with the following terms of
reference:
I.
Review existing histamine related guidance in the Code of Practice for Fish and Fishery Products
(CAC/RCP 52-2003) and any guidance documents used in member countries to decide whether
the current Code is sufficient for histamine control guidance.
II. Consider inclusion of the susceptible species list contained in Table 2.3 of the Joint FAO/WHO
Expert Meeting.
III. Continue to consider the application of an uncertainty factor and the safety limits for histamine in
the standards for fish and fishery products and make recommendations on these limits, and to
consider other risk management options, e.g. consumer advice, and whether there was a need for
the decomposition limits in the standards.
IV. Continue to consider appropriate sampling plans for histamine.
A total of 28 countries and observers registered to participate in the working group. Appendix 1 lists the
EWG participants and their email addresses.
I. CONTROL GUIDANCE
Background
The Meeting Report of the Joint FAO/WHO Expert Meeting on the Public Health Risks of Histamine and
Other Biogenic Amines from Fish and Fishery Products; 23–27 July 20121 (FAO/WHO Expert Report)
concluded in Section 6.4 that,
For most products, the risk of SFP can be suitably mitigated by rapid chilling of the raw material
and maintaining the cold chain. For such products SFP will only occur when they have been
subjected to gross time/temperature abuse. However, for other products, such as smoked and
fermented products, other controls may be needed.
The previous electronic working group (CX/FFP 14/33/12G)2 and the 33rd Session physical working
1
Meeting Report of the Joint FAO/WHO Expert Meeting on the Public Health Risks of Histamine and
Other Biogenic Amines from Fish and Fishery Products; 23–27 July 2012.
Link: http://www.fao.org/fileadmin/user_upload/agns/news_events/Histamine_Final_Report.pdf
2
CX/FFP 14/33/12
1
group (FFP 33 CRD 21)3 recommended that CCFFP should review the Code of Practice for Fish and
Fishery Products to determine if control of histamine is adequately covered.
Discussion
Maintenance of the cold chain is covered in the Code of Practice for Fish and Fishery Products (COP);
however there is opportunity to provide more specific guidance on histamine control, particularly for
harvest vessels. Locations in the COP where additional histamine guidance could be included are listed
in Appendix 2.
Fermented products, other than fish sauce (under development), are not covered in the COP.
Recommendation
1) Form a working group to revise and elaborate histamine guidance in the Code of Practice for Fish and
Fishery Products.
2) Consider if specific guidance for fermented or dried products is needed. If so, then form a working
group to research and propose draft guidance for these products.
II. SUSCEPTIBLE SPECIES (Table 2.3, FAO/WHO Expert Report)
Background
From Section 2.6 of the FAO/WHO Expert Meeting Report:
Table 2.3 lists fish species that have been associated with SFP [scombrotoxic fish poisoning] or
elevated levels of free histidine.
Fish in the Salmonidae family were included in this table not on the basis of free histidine
content, but rather on reported illnesses of SFP-like intoxication.
The information provided in Table 2.3 is not ranked in terms of risk for individual fish species
because this is challenging from a global perspective. However the meeting recognized that
individual countries or regions may need to rank fish species according to their particular
situation and needs.
Discussion
The Code of Practice for Fish and Fishery Products refers to fish species susceptible to scombrotoxin. It
would benefit readers of the Code to have access to a more complete list of commercial fish species that
could develop scombrotoxin.
The histamine hazard may not always be significant for all the species in the Table 2.3. The hazard
analysis should take into account historic histamine data for the fishery, and if histamine would likely
Link: ftp://ftp.fao.org/codex/meetings/ccffp/ccffp33/fp33_12e.pdf
3
FFP 33 CRD 21
Link: ftp://ftp.fao.org/codex/meetings/CCFFP/CCFFP33/CRDs/CRD_21.pdf
2
reach hazardous levels in the absence of temperature controls. Susceptible species harvested from colder
water and/or during colder seasons are less susceptible to histamine formation on the harvest vessel
because they have less chance to be exposed to elevated temperature.
Recommendation
1) Include Table 2.3 as an appendix in the Code of Practice for Fish and Fishery Products. The histidine
content and production data in Table 2.3 shows why the species was included and this data could be
excluded for the purposes of the COP.
2. Proposed introductory wording and locations in the COP where the list could be cited are shown in
Appendix 3.
III. SAFETY LIMIT
Background
The roll of the commodity committee in risk analysis/risk management is explained in the “Working
Principles for Risk Analysis for Application in the Framework of the Codex Alimentarius” in the Codex
Procedural Manual, 22st version (page 109). CCFFP is the risk management body responsible for
determining the appropriate histamine safety limit in standards by considering the risk assessment and
uncertainty discussed in the FAO/WHO Expert Report, other legitimate factors, and options for public
protection.
The FAO/WHO Expert Report identified the no observed adverse effects level (NOAEL) for histamine in
humans, and determined that 200 mg/kg of histamine in fish, based on 95% of maximum average
consumption, would provide a histamine dosage at the threshold of possible adverse effects in healthy
adults.
The Report discussed the applicability and uncertainty of the NOAEL on page 33 (brackets from page
105),
It is important to bear in mind that, while the NOAEL is an appropriate hazard threshold value to
use for exposures in healthy subjects, this may not be the case for those members of certain
segments of the population who may have an increased sensitivity (e.g. metabolic differences,
physiological conditions, drug therapies). In these instances a lower hazard level may need to be
considered (e.g. the use of an uncertainty factor [of 10]) or other specific risk management
options such as fish consumption advisories should be considered.
And on page 34 (brackets show number of subjects used in the two studies),
This dosage level will not apply to individuals with a specific sensitivity to histamine and would
not apply to children, particularly because they consume more food per unit body weight than
adults. It is also important to bear in mind that the 50 mg dosage was derived from data on a
small number of subjects [n=8, n=8], and while the variation of response appears to be reflected
in the study results further studies would be most helpful in refining this threshold value.
During the previous electronic working group, most countries supported to continue studying the
histamine safety limit, or lowering the limit (as low as 20 mg/kg). There was particular concern with the
protection of children. Also discussed were common conditions that increase histamine sensitivity (e.g.,
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alcohol, smoking), concurrent consumption of other histamine containing foods, and a likely potentiation
effect caused by co-occurring biogenic amines. During the in session physical working group during the
33rd Session, one participant suggested lowering the limit to 100 mg/kg to account for children, while
another participant suggested retaining the current limit and using consumption advisories for protection.
Discussion
Some countries support a moderately lower 100 mg/kg limit because it would account for children that
generally have greater consumption levels relative to body weight than adults, which is not accounted for
in the current 200 mg/kg limit. Other countries believe that the current 200 mg/kg limit is adequate, and
perhaps advisories can be used for additional protection.
The proposed 100 mg/kg safety limit (no sample shall exceed) is close to the current 100 mg/kg
decomposition limit (sample average) and therefore would not materially affect industry requirements
under Codex fish standards; however, identifying the safety nature of this limit should help achieve more
consistent implementation of controls.
Using consumer education/public advisories (e.g., to protect children) is an option; however, this
approach may lead to lower fish consumption, which may not be desired because fish generally provide
health benefits (e.g., omega-3 oils in fish are important for child brain development). Advisories may
also be viewed as unwarranted by the fish industry because the majority of producers maintain very low
histamine levels.
Histamine is a bacterial decomposition product of histidine (naturally found in fish muscle), and is used
as a chemical indicator of bacterial decomposition caused by temperature abuse of susceptible fish
species. However, if the histamine safety limit is lowered to 100 mg/kg, then the 100 mg/kg
decomposition limit should be removed from standards because it would become irrelevant and a source
of confusion.
Recommendation
1) Lower the histamine safety limit in standards from 200 mg/kg to 100 mg/kg.
2) If the safety limit is lowered to 100 mg/kg, remove the histamine decomposition limit as irrelevant and
a source of confusion.
[If any member of the EWG does not support these recommendations 1) and 2), please provide an
alternative approach and its justifications.]
3) Consider new work to review chemical indicators of decomposition and to propose guidance and/or
indicator limits.
IV. SAMPLING PLANS
Background
FAO/WHO developed the Histamine Sampling Tool4 for countries to use to create and evaluate histamine
sampling plans in a statistical risk-based manner.
4
Link to FAO/WHO Histamine Sampling Tool: http://www.fstools.org/histamine/
4
During previous working group discussions most countries were in agreement that good vessel and
manufacturing practices and HACCP systems are the best methods to control histamine. Regulatory
authorities use histamine sampling to help verify that these controls are in place, rather than to assure
product safety, which was viewed as impractical.
Discussion
Countries use simple or sophisticated sampling strategies to achieve the degree of protection desired with
available resources. Risk-based sampling strategies may be used that vary the sampling frequency and/or
sample size based on past results of histamine sampling for the particular product and manufacturer.
If a fixed sample size plan were considered for fish standards, it should be recognized that for consumer
protection within the Codex framework, the sample size and decision limit should provide statistically
justifiable protection. As discussed above, however, most countries believe that it is not practical to
assure public safety through sampling because of the large sample sizes and low decision limits required.
In standards currently, if any sample in the lot exceeds the histamine safety limit, the lot is out of
compliance. This is justifiable because product found in that lot could cause illness. However, countries
generally draw far fewer samples to determine compliance with the safety limit than could be justified
based on a statistically based sampling plan alone. As a practical matter, regulatory authorities weigh
performance and costs when choosing sampling plans as part of their overall regulatory strategy.
Providing a reference to the FAO/WHO Histamine Sampling Tool is an alternative to providing a fixed
histamine sampling plan for fish standards. This approach would provide information and choices for
appropriate sampling plans.
Recommendation
1) Retain the current safety limit wording in standards, i.e., “The product shall not contain histamine that
exceeds X”, and/or “The product shall not contain more than X histamine in any sample unit tested”.
2) Reference the FAO/WHO Histamine Sampling Tool in fish standards, or possibly in the Fish and
Fishery Products Code of Practice, which is cited in fish standards.
Possible revised wording for the sampling section in fish standards:
Sampling of lots for examination of the final product shall be in accordance with the General
Guidelines on Sampling (CAC/GL 50-2004). The FAO/WHO Sampling Tool for Histamine
(http://www.fstools.org/histamine/Default.aspx) provides statistical information for
designing and analyzing histamine sampling plans.
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Appendix 1 - List of Participants
Argentina
Barbara Castellani
bcastellani@minagri.gob.ar
Fabian Ballesteros
fballest@senasa.gov.ar
Ms Geneviève MORHANGE
genevieve.morhange@dgccrf.finances.gouv.fr
Ms Virginie Hossen
virginie.hossen@agriculture.gouv.fr
Mr Guillaume DUFLOS
guillaume.duflos@anses.fr
Lic. Silvana Ruarte
sruarte@anmat.gov.ar
Ghana
Argentina Codex Contact Point
codex@minagri.gob.ar
Dr. Lawrence D. Abbey
abbeyld@yahoo.com
Australia
Mr. Meinster Bonneford Kodjo Eduafo
keduafo@yahoo.ocm
meinsterkodjoeduafo@rocketmain.com
Lynda Hayden
lynda.hayden@agriculture.gov.au
Iceland
Brazil
Lucio Akio Kikuchi
lucio.kikuchi@agricultura.gov.br
Chile
Francoise Barbe
fbarbe@sernapesca.cl
Ms Dora Gunnarsdottir
dora.gunnarsdottir@mast.is
Mr. Gardar Sverrisson
gardar.sverrisson@mast.is
India
Croatia
Dr. Satyen Kumar Panda
satyenpanda@gmail.com
Tanja Bogdanovic
t.bogdanovic.vzs@veinst.hr
NCCP, India
Codex-india@nic.in
Egypt
Iran
Hoda Mohamed Fathi
hfathi55@yahoo.com
Afsaneh Samiei
fishcommittee@gmail.com
European Union
Yazdan Morady
ymorady@yahoo.com
Mr. Paolo Caricato
paolo.caricato@ec.europa.eu
Iraq
EU Codex contact point
codex@ec.europa.eu
Miss. Manal Salman Mohammed
altaee_manal@yahoo.com
France
Japan
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Dr. Rei Nakagawa
codexj@mhlw.go.jp
codex_maff@nm.maff.go.jp
Dr Ibrahima Cisse
ibrahima_cisse@hotmail.com
South Africa
Mr. Hirohide Matsushima
hirohide_matsushima@nm.maff.go.jp
Ms. Tomoe MUKAE
tomoe_mukae@nm.maff.go.jp
Mauritius
Mrs Madvi Jugnarain
mjugnarain@mail.gov.mu
Mr Deon Jacobs
JACOBSDC@nrcs.org.za
Spain
Julian Garcia Baena
JGBaena@magrama.es
Victoria Ruiz Garcia
riesgosbiologicos@msssi.es
Mexico
Muncino Gabriela Brito
gmucinob@cofepris.gob.mx
Sara Gomez Troyano
riesgosbiologicos@msssi.es
Sweden
Ines Alvarez Perez
ialvarez@cofepris.gob.mx
Mrs. Carmina Ionescu
carmina.ionescu@slv.se
New Zealand
Thailand
Jim Sim
jim.sim@mpi.govt.nz
Norway
Manat Larpphon
manat@acfs.go.th
mlarpphon@yahoo.com
codex@acfs.go.th
Bjørn Tore Lunestad
blu@nifes.no
United States of America
Geir Olav Valset
geir.valset@mattilsynet.no
Paulo Almeida
paulo.almeida@fsis.usda.gov
Vigdis S. Veum Moellersen
visvm@mattilsynet.no
FAO FIPM
Poland
Codex Contact Point for Poland
kodeks@ijhars.gov.pl
Russia
Karunasager Iddya
iddya.karunasagar@fao.org
Bangladesh Rural Development Organization
Md.Mazharul Islam
Rural.development.bd@gamil.com
Sergey Hotimchenko
hotimchenko@ion.ru
Senegal
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Appendix 2 – Locations in the Code of Practice for Fish and Fishery Products to consider
revised and/or new scombrotoxin (histamine) guidance
SECTION 3 - PREREQUISITE PROGRAMME
3.1 Fishing and harvesting vessel design and construction
3.1.2 To minimize contamination
Could include guidance on design and construction of ice storage, refrigeration, and fish holding
systems.
3.2 Facility design and construction
3.2.2 To minimize contamination
Could include guidance on design and construction of refrigeration and fish holding systems.
3.4 Hygiene control programme
Could include subsection on temperature/ice monitoring programs and related training needs.
SECTION 4 – GENERAL CONSIDERATION FOR THE HANDLING OF FRESH FISH, SHELLFISH
AND OTHER AQUATIC INVERTEBRATES
4.1 Time and temperature control
Section 4.1 discusses scombrotoxin production generally, but does not mention or specifically
discuss harvest vessels. Harvest vessels are an important control point for scombrotoxin
production.
Note that Section 8 covers scombrotoxin control during processing of fresh, frozen, and minced
fish at the processing facility only.
CCFFP may decide if information specific to harvest vessels should be included in Section 4, or
if a new section should be drafted specific for Harvest Vessels, similar to Section 17 for
Transportation.
In addition Section 4.1 could list sectors of the food chain where the existing guidance applies
(e.g., harvest vessels, processing facilities, transportation), and could include further general
information on scombrotoxin, for example:
 High and low temperature scombrotoxin formation
 Role of heat and freezing on enzyme and toxin
 Role of fish size
Examples of information that could be included for harvest vessels:
 Rapid chilling, chilling methods, role of evisceration
 Monitoring air temperature, water temperature, fish temperature, and time of exposure
 Longlining, gillnetting
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SECTION 8 – PROCESSING OF FRESH, FROZEN AND MINCED FISH
8.1.1 Raw, fresh or frozen fish reception (Processing Step 1)
Section 8.1.1 suggests developing product specifications; however it does not provide guidance on
scombrotoxin controls at reception. Reception of raw material at the processing facility is considered
an important control point for scombrotoxin where the hazard may not have been controlled on
harvest vessels and/or during transportation.
Guidance could be included on controlling scombrotoxin in susceptible species at reception, for
example:





Monitoring of incoming fish temperature and/or adequacy of ice
Monitoring transportation temperature records
Monitoring harvest vessel temperature records
Monitoring histamine levels
Monitoring organoleptic signs of decomposition
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Appendix 3 – FAO/WHO Susceptible Species List (Table 2.3)5
Table 2.3 could be included as an appendix to the COP. The 4th and 5th columns that include data on
histidine levels and annual production could be excluded.
Suggested language to introduce the list:
Appendix X. Names of fish species susceptible to scombrotoxin fish poisoning
The scombrotoxin (histamine) hazard may not always be significant for all the fish in this
list. The hazard analysis should take into consideration if scombrotoxin formation would
likely reach hazardous levels in the absence of appropriate controls. Susceptible species
harvested from colder water and/or during colder seasons are less susceptible to histamine
formation on the harvest vessel because they have less chance to be exposed to elevated
temperature.
Listed below are locations in the Code of Practice for Fish and Fishery Products that reference
susceptible species and where a footnote to the FAO/WHO Susceptible Species List might be appropriate
(marked by x). Related suggested edits are marked by bold underline:
SECTION 4 – GENERAL CONSIDERATIONS FOR THE HANDLING OF FRESH FISH,
SHELLFISH AND OTHER AQUATIC INVERTEBRATES
4.1 Time and temperature control, 2nd line:
For species prone susceptible to scombrotoxin productionx, time and temperature control may be
the most effective method for ensuring food safety.
SECTION 8 – PROCESSING OF FRESH, FROZEN AND MINCED FISH
8.1.1 Raw, fresh or frozen fish reception, 2nd bullet:
Warranting special consideration are the reception and sorting of fish species that pose a risk of
biotoxins such as…scombrotoxin in scombroid species susceptible to scombrotoxin
productionx…
8.1.4 Controlled thawing, 2nd bullet:
Thawing time and temperature and fish temperature critical limits should be selected so as to
control the development of micro-organisms and histamine (where high-risk species are
concernedx) or persistent and distinctive objectionable odours or flavours indicative of
decomposition or rancidity.
SECTION 9 – PROCESSING OF FROZEN SURIMI
9.1.1 Hazards, 2nd paragraph:
5
Table 2.3, Joint FAO/WHO Expert Meeting on the Public Health Risks of Histamine and Other Biogenic Amines
from Fish and Fishery Products.
10
If scombrotoxin-forming fishx such as tuna or mackerel…are utilized for surimi, appropriate
controls for these hazards should be developed.
SECTION 11 – PROCESSING OF SALTED AND DRIED SALTED FISH
11.1 General, 6th bullet:
When fish that accumulate histaminex are being salted, exposure to temperatures that would
support toxin formation by bacteria should be limited at each step in the process.
11.4.6 Maturing, 2nd bullet:
The first part of curing period for fish that accumulate histaminex should be done at temperatures
between 0 °C and 5 °C to prevent development of histamine.
11.4.6 Maturing, last bullet:
When salting fish that accumulate histaminex, regular checks should be made of histamine
content of the end product.
SECTION 12 – SMOKED FISH, SMOKE-FLAVOURED FISH AND SMOKE-DRIED FISH
12.1.2 Salting, 3rd bullet, 1st line:
Salting time and temperature and fish temperature should be selected so as to control the
development of histamine, where fish of susceptible speciesx are concerned (e.g. Scombridae,
Clupeidae, Engraulidae, Coryphaenidae, Pomatomidae, Scomberesocidae).
12.1.4 Drying, 4th bullet:
Drying should not result in prolonged exposure to ambient temperature as this may lead to
unwanted microbiological growth and to formation of histamine in susceptible speciesx.
SECTION 16 – PROCESSING OF CANNED FISH, SHELLFISH AND OTHER AQUATIC
INVERTEBRATES
16.2.1 Hazards, A2 Scombrotoxins, 2nd line:
Good practices for the conservation and handling from capture to heat processing are essential to
preventing histamine production in susceptible speciesx.
16.4.1.1 General considerations, 5th bullet:
Care should be taken to prevent temperature abuse of scombrotoxic species susceptible to
scombrotoxin productionx before precooking.
ANNEX 1. POTENTIAL HAZARDS ASSOCIATED WITH FRESH FISH, SHELLFISH AND OTHER
AQUATIC INVERTEBRATES
1.5 Scombrotoxin, 3rd line:
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The main susceptible fishx are the scombroids such as tuna, mackerel, and bonito, although it can
be found in other fish families such as Clupeidae.
12